RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D
An Open-Label, First-in-Human Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With Type 1 Diabetes Mellitus (T1D)
About This Trial
This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D
Who May Be Eligible (Plain English)
Who May Qualify:
- Diagnosis of T1D for a minimum of 5 years
- Stable diabetes regimen for at least 3 months prior to enrollment.
Who Should NOT Join This Trial:
- Medical history of islet cell, kidney, and/or pancreas transplant
- Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment
- Known causes of diabetes other than T1D
- Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study
- Prior treatment with gene therapy or edited product
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Diagnosis of T1D for a minimum of 5 years
* Stable diabetes regimen for at least 3 months prior to enrollment.
Exclusion Criteria:
* Medical history of islet cell, kidney, and/or pancreas transplant
* Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment
* Known causes of diabetes other than T1D
* Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study
* Prior treatment with gene therapy or edited product
Treatments Being Tested
COMBINATION_PRODUCT
VCTX211
CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device
Locations (2)
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada